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TN DCA to introduce digital services for accepting applications & issuing licenses for pharma manufacturers

Peethaambaran Kunnathoor, Chennai
Thursday, February 28, 2019, 08:00 Hrs  [IST]

Aiming to provide quick services to the manufacturing industry and make the process of submission of application and issuance of licenses more transparent, the Tamil Nadu drugs control administration (TN DCA) will soon introduce online licensing system for drug manufacturers.

Currently online facility for approvals is available only for the traders. From April onwards, licensing process for the manufacturing industry and the trade industry will be carried out using digital services.

The application software will be linked to the central drugs control office’s ‘sugam’ portal as the licence is issued only after a joint inspection by the inspectors of central and state governments. No physical applications will be accepted, nor any licence/certificate will be sent manually to anybody for any kind of approval. Digital submission of applications will be in force in next two months, said S Sivabalan, director of drugs control administration.

“Government is planning to make all process transparent and user friendly. Already sale licences are issued to the traders through online. Now we are going for digital services for the industry also. Software for the system is getting ready with the Tamil Nadu e-governance department. It is linked with the CDSCO’s ‘sugam’ portal. The system of approval will help 540 pharma manufacturers in the state”, said the DC.

He said, on receiving applications online, drug inspectors from central and state will jointly conduct investigations at the manufacturing sites. Previously joint inspection was conducted only for blood bank licensing. From February 27, 2017 a new rule has come for joint inspection at manufacturing sites of medicines and medical devices.

To a question, the DC said two approvals were already given for medical devices after a thorough inspection by central and state inspectors at the sites of medical devices manufacturers. But for the A and B category devices the state licensing authorities are not authorized to issue licenses. Medical devices rules 2017 came into effect from January 1, 2018.


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